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Preparation method of insulin detemir injections and insulin detemir injection prepared by using method

A technology for insulin detemir and injection, which is applied to medical preparations containing active ingredients, pharmaceutical formulas, endocrine system diseases, etc., to achieve the effects of shortening the preparation time, ensuring drug safety and improving quality

Active Publication Date: 2015-06-10
TONGHUA DONGBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the increased tendency of insulin detemir to coagulate due to physical and mechanical stress under the preparation conditions, it is inevitable to use physical means such as stirring during the preparation of injections, thereby bringing undesirable impurities to the preparation

Method used

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  • Preparation method of insulin detemir injections and insulin detemir injection prepared by using method
  • Preparation method of insulin detemir injections and insulin detemir injection prepared by using method
  • Preparation method of insulin detemir injections and insulin detemir injection prepared by using method

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preparation example Construction

[0044]Preparation method 1 (preparation method provided by the present invention): (1) take a 1L beaker, add the rotor, place it on a magnetic stirrer, add glycerin and 600mL water for injection, stir to dissolve the glycerin and prepare a glycerin solution; (2) diazepam Insulin, m-cresol, and phenol are pre-dissolved with 180mL, 300mL, and 120mL of the glycerol solution respectively to obtain insulin detemir-glycerol solution, m-cresol-glycerol solution and phenol-glycerol solution; (3) the insulin detemir- Glycerol solution, m-cresol-glycerin solution and phenol-glycerin solution are mixed, stirred evenly, obtain mixed solution I; (4) under stirring, add the sodium hydroxide solution of 0.1mol / L in described mixed solution I to pH= 9.0 to 9.5, so that insulin detemir dissolves rapidly and the solution becomes clear; (5) Take three 25mL beakers, add zinc acetate, sodium chloride and disodium hydrogen phosphate respectively, and add 5mL water for injection to dissolve and prepa...

Embodiment 1

[0048] Example 1 Insulin detemir injection prepared by different methods

[0049] The insulin detemir injection described in this implementation contains insulin detemir 100IU / mL, glycerol 16mg / mL, m-cresol 2.06mg / mL, phenol 1.8mg / mL, zinc 65.4μg / mL, sodium chloride 1.17mg / mL, Disodium hydrogen phosphate 0.89mg / mL, hydrochloric acid, sodium hydroxide and water for injection, pH=7.4; prepare insulin detemir injection according to the above-mentioned preparation method 1, preparation method 2 and preparation method 3, and record the required preparation cycle time, the results are shown in Table 1.

Embodiment 2

[0050] Example 2 Insulin detemir injection prepared by different methods

[0051] The insulin detemir injection described in this implementation contains insulin detemir 100IU / mL, glycerin 17mg / mL, m-cresol 2.2mg / mL, phenol 1.5mg / mL, zinc 65.4μg / mL, sodium chloride 1.1mg / mL, Disodium hydrogen phosphate 0.89mg / mL, hydrochloric acid, sodium hydroxide and water for injection, pH=7.4; prepare insulin detemir injection according to the above-mentioned preparation method 1, preparation method 2 and preparation method 3, and record the required preparation cycle time, the results are shown in Table 1.

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Abstract

The invention provides a preparation method of insulin detemir injections and an insulin detemir injection prepared by using the method. The preparation method mainly comprises the following steps: dissolving glycerol by using a part of water for injection so as to obtain a glycerol solution, dividing the glycerol solution into three parts, and respectively adding the three parts into insulin detemir, m-cresol and phenol; uniformly mixing the three solutions firstly so as to obtain a mixed solution I, and regulating the pH value of the mixed solution I to 9.0-9.5; respectively dissolving zinc acetate, sodium chloride and sodium hydrogen phosphate by using a part of water for injection, sequentially adding the obtained solutions into the mixed solution I, and regulating the pH value of the obtained solution I to 7.3-7.5 by using a hydrochloric acid solution; and finally, adding the obtained object by using the water for injection until a final volume is reached. According to the preparation method disclosed by the invention, insulin detemir and other auxiliary materials can be dissolved quickly, so that the preparation period of time is significantly shortened, technological impurities produced in the preparation process are reduced, the quality of insulin detemir injections is improved, the technological energy consumption is reduced, and the production speed is improved, therefore, the preparation method is better suitable for the needs of large-scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a method for preparing insulin detemir injection and the prepared insulin detemir injection. Background technique [0002] Insulin detemir is a long-acting analog of human insulin used in adults and children with type 1 diabetes and in adults with type 2 diabetes. Insulin detemir can form a stable double hexamer after subcutaneous injection, which has a stable and long-lasting effect, and can also reversibly combine with plasma albumin, and has a relatively gentle time action curve. While effectively controlling fasting blood sugar, it can also cause blood sugar Fluctuation and hypoglycemia adverse reactions are less. Because of its long-acting properties, insulin detemir only needs to be administered by subcutaneous injection 1-2 times a day at a fixed time. Type 1 diabetic patients and type 2 diabetic patients whose oral hypoglycemic drugs fail need to u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/28A61K9/08A61P5/48
Inventor 郭银汉武晓丽王文娜詹巾卓孙洪艳牛丁赵颖秦丽静
Owner TONGHUA DONGBAO PHARMA